NCT07488325

Brief Summary

The prospective study aim to develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 10, 2026

Last Update Submit

March 30, 2026

Conditions

Thyroid Nodule

Keywords

Thyroid NoduleAtypia of Undetermined SignificanceMultimodal Deep LearningUltrasoundCytology Whole-Slide Image

Outcome Measures

Primary Outcomes (1)

  • Pathological diagnosis.

    WHO guidelines.

    One month after the surgery.

Study Arms (2)

Benign thyroid nodule

Confirmed by histopathology.

Other: Histopathology or cytopathology.

Malignant thyroid nodule

Confirmed by histopathology.

Other: Histopathology or cytopathology.

Interventions

Histopathology or cytopathology.OTHER

This is a observation stufy.

Benign thyroid noduleMalignant thyroid nodule

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a Bethesda Ⅲ thyroid nodule

You may qualify if:

  • (a) Patients who underwent fine-needle aspiration of thyroid nodules and received a cytological diagnosis of Bethesda Ⅲ.
  • (b) Patients who subsequently underwent thyroid surgery with a definitive histopathological diagnosis of benign or malignant lesions,.
  • (c) Availability of at least one ultrasound image acquired prior to surgery.

You may not qualify if:

  • (a) Patients without confirmation by surgical pathology,.
  • (b) Patients without any available or usable ultrasound images.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Memorial Hospital

Guangzhou, Guangzhou, 510288, China

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Jingliang Ruan, Ph.D.

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingliang Ruan, Ph.D.

CONTACT

+8613694202230ruanjl3@mail.sysu.edu.cn

Xinmin Xiao, B.S.

CONTACT

+8618420058253

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 23, 2026

Study Start

March 1, 2026

Primary Completion

June 30, 2026

Study Completion

July 15, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

CN(1)